Intrahepatic Cholestasis Associated With Alcoholic Liver DiseasePhase 3NCT02200029
Study With Heptral in Subjects With Liver Disease Due to Alcohol Consumption
A Phase 3 study testing Ademetionine IV+tablet and Ademetionine tablet in people with Intrahepatic Cholestasis Associated With Alcoholic Liver Disease, run by Abbott at 12 sites in Russia.
Trial summary
A research study of an approved drug called Heptral®, ademetionine, to treat adults with intrahepatic cholestasis (a condition where bile cannot flow from the liver to the duodenum) in pre-cirrhotic and cirrhotic states. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Intrahepatic Cholestasis Associated With Alcoholic Liver Disease
- What is being tested?
- Ademetionine IV+tablet and Ademetionine tablet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 12 sitesRussia
- Study dates
- Jun 2014to Feb 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent given by the subject
- Age ≥ 18 years to 75 years
- Chronic liver disease due to alcoholic liver disease
- Compensated alcoholic liver disease, defined as having a Maddrey Score < 32 and not being treated with pentoxifylline or prednisolone within 6 months prior to the study
- History of chronic alcohol use, defined as, history of consumption of > 40 g of alcohol per day for females and > 80 g alcohol per day for males for more than 5 years prior to enrolment
- Subjects who abstain from alcohol for more than 2 weeks and will not consume alcohol during the study
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- Subjects with Intrahepatic Cholestasis (IHC):
- ALP: more than 1.5 x upper normal limit and
- γGT: more than 3 x upper normal limit
- Subjects with additional serum conjugated bilirubin (SCB) > Upper Limit of Normal (ULN) will be selected for initial IV treatment
Who cannot join
- Subjects with a known hypersensitivity to the active substance of ademetionine or to any of the inactive ingredients
- Subjects with extrahepatic cause of cholestasis (proven by ultrasound or described in medical history)
- Diagnosis of human immunodeficiency virus (HIV) in medical history
- Subjects with chronic liver disease Child-Pugh class C
- Subjects in the decompensation stage of ALD (such as Maddrey Score >32)
- Subjects with primary sclerosing cholangitis (PSC)
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- Subjects with primary biliary cirrhosis (PBC)
- Any form of malignancy within the past 5 years and/or basal cell carcinoma and squamous cell carcinoma of the skin within the past two years
- Subjects with drug-induced liver disease
- History of active substance abuse (oral, inhaled or injected) within one year prior to the study
- Subjects with renal impairment (creatinine level of >2.0 mg/dL or > 150 µmol/l)
- Subjects with known genetic defects affecting the methionine cycle and/or causing homocystinuria and/or hyperhomocysteinemia (e.g., cystathionine beta-synthase deficiency, Vitamin B12 metabolism defect) or known folate, Vitamin B6 or B12 deficiency
- Subjects on total parenteral nutrition in the year prior to screening
- Subjects after or planned for bariatric surgery (jejunoileal bypass or gastric weight loss surgery)
- Subjects after liver transplantation and subjects on the waiting list for liver transplantation
- Subjects with any of the following disease in medical history:
- Viral hepatitis (serum positive HBcAb or Hepatitis C Virus (HCV) RNA)
- Evidence of autoimmune liver disease
- Wilson´s disease
- Hemochromatosis
- Alpha-1-antitrypsin deficiency
- Subjects with history of biliary diversion
- History of major depression or bipolar disease
- Women of childbearing potential: positive urine pregnancy test during screening or unwillingness to use an effective form of birth control during the study.
- Breastfeeding women
- Any condition that, in the opinion of the investigator, does not justify the patient's inclusion into the study
- Investigational drug intake within one month prior to the study
- Active, serious medical disease other than ALD with likely life-expectancy less than five years
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Russia12 sites
Research facility ORG-000962
Moscow, 107014
Research facility ORG-000957
Moscow, 117292
Research facility ORG-000961
Moscow, 119435
Research facility ID ORG-000960
Moscow, 119992
Research facility ID ORG-000726
Moscow, 125284
Research facility ORG-000967
Saint Petersburg, 117630
Research facility ORG-000966
Saint Petersburg, 191015
Research facility ORG-000968
Saint Petersburg, 195257
Research facility ORG-000965
Saint Petersburg, 197022
Research facility ORG-000970
Saint Petersburg, 198216
Research facility ORG-000958
Troitsk, 142190
Research facility ORG-000969
Yaroslavl, 150003
About this study
Official title: Open-Label Study With Ademetionine (Heptral®) in Subjects With Intrahepatic Cholestasis (IHC) Associated With Alcoholic Liver Disease (ALD)
A research study of an approved drug called Heptral®, ademetionine, to treat adults with intrahepatic cholestasis (a condition where bile cannot flow from the liver to the duodenum) in pre-cirrhotic and cirrhotic states. Experience from clinical studies in subjects with liver disease has shown that ademetionine is effective.
- Being tested
- Ademetionine IV+tablet, Ademetionine tablet
- Keywords
- Intrahepatic Cholestasis
- Medical subject headings
- Cholestasis, Intrahepatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ademetionine IV+tabletDrug
IV ademetionine (500 mg/vial) for 2 weeks followed by oral ademetionine (500 mg/tablet, 2 in the morning and 1 before dinner) for 6 weeks
Ademetionine tabletDrug
oral ademetionine (500 mg/tablet, 2 in the morning and 1 before dinner) for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Ademetionine IV | Experimental | Not described Receives: Drug: Ademetionine IV+tablet |
| Ademetionine oral | Experimental | Not described Receives: Drug: Ademetionine tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentrations (Units per liter) of Alkaline phosphatase (ALP) or gamma-glutamyltransferase (γGT)
Improvement of ALP or γGT after 8 weeks of treatment with ademetionine compared to baseline
Measured: from baseline up to the end of treatment visit (56-60 days)
Secondary outcomes (3)
Concentrations of ALP, γGT, Alanine Transaminase (ALT) and Aspartate aminotransferase (AST) (Units per liter) and of serum total and conjugated bilirubin (µmol per liter)
Improvement of ALP, γGT and serum total and conjugated bilirubin, ALT and AST compared to baseline
Measured: At baseline and after 2 weeks intravenously (IV) treatment or after 4 weeks oral treatment and after 2 months treatment
The intensity of clinical symptoms (jaundice, pruritus, fatigue and depressed mood) will be recorded for each symptom separately using six categories: No symptoms (0), minimum (1) to maximum (5).
Record of intensity of jaundice, pruritus, fatigue and depressed mood compared to baseline
Measured: At baseline and after 2 weeks IV treatment or after 4 weeks oral treatment and after 2 months treatment
Evaluation of the responder rate by comparing concentrations at certain time points (units per liter) to baseline concentrations
>20% reduction of ALP or γGT or normalization of ALP or γGT compared to baseline
Measured: At baseline and after 2 weeks IV treatment or after 4 weeks oral treatment and after 2 months treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrahepatic Cholestasis Associated With Alcoholic Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ascent, Datamap, ClinIntel, Catalent
- Responsible party
- Sponsor
- Investigators
- Suntje Sander-Struckmeier, PhD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02200029
- Sponsor's protocol ID
- M14-168
- Status last verified
- Jun 2015
- First submitted
- 21 Jul 2014
- Last updated
- 16 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Study With Ademetionine (Heptral®) in Subjects With Intrahepatic Cholestasis (IHC) Associated With Alcoholic Liver Disease (ALD)
- ClinicalTrials.gov ID
- NCT02200029
- Acronym / sponsor ID
- M14-168
- Keywords
- Intrahepatic Cholestasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Collaborators
- Ascent, Datamap, ClinIntel, Catalent
- Study start
- Jun 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 25 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A research study of an approved drug called Heptral®, ademetionine, to treat adults with intrahepatic cholestasis (a condition where bile cannot flow from the liver to the duodenum) in pre-cirrhotic and cirrhotic states. Experience from clinical studies in subjects with liver disease has shown that ademetionine is effective.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ademetionine IV | Experimental | Drug: Ademetionine IV+tablet |
| Ademetionine oral | Experimental | Drug: Ademetionine tablet |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed informed consent given by the subject
- Age ≥ 18 years to 75 years
- Chronic liver disease due to alcoholic liver disease
- Compensated alcoholic liver disease, defined as having a Maddrey Score < 32 and not being treated with pentoxifylline or prednisolone within 6 months prior to the study
- History of chronic alcohol use, defined as, history of consumption of > 40 g of alcohol per day for females and > 80 g alcohol per day for males for more than 5 years prior to enrolment
Key exclusion criteria (28 listed)
- Subjects with a known hypersensitivity to the active substance of ademetionine or to any of the inactive ingredients
- Subjects with extrahepatic cause of cholestasis (proven by ultrasound or described in medical history)
- Diagnosis of human immunodeficiency virus (HIV) in medical history
- Subjects with chronic liver disease Child-Pugh class C
- Subjects in the decompensation stage of ALD (such as Maddrey Score >32)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ademetionine IV+tabletIV ademetionine (500 mg/vial) for 2 weeks followed by oral ademetionine (500 mg/tablet, 2 in the morning and 1 before dinner) for 6 weeks | Drug | Ademetionine IV |
| Ademetionine tabletoral ademetionine (500 mg/tablet, 2 in the morning and 1 before dinner) for 8 weeks | Drug | Ademetionine oral |
Primary outcome
Concentrations (Units per liter) of Alkaline phosphatase (ALP) or gamma-glutamyltransferase (γGT)
Time frame: from baseline up to the end of treatment visit (56-60 days)
Improvement of ALP or γGT after 8 weeks of treatment with ademetionine compared to baseline
3 secondary outcomes
Concentrations of ALP, γGT, Alanine Transaminase (ALT) and Aspartate aminotransferase (AST) (Units per liter) and of serum total and conjugated bilirubin (µmol per liter)
Time frame: At baseline and after 2 weeks intravenously (IV) treatment or after 4 weeks oral treatment and after 2 months treatment
The intensity of clinical symptoms (jaundice, pruritus, fatigue and depressed mood) will be recorded for each symptom separately using six categories: No symptoms (0), minimum (1) to maximum (5).
Time frame: At baseline and after 2 weeks IV treatment or after 4 weeks oral treatment and after 2 months treatment
Evaluation of the responder rate by comparing concentrations at certain time points (units per liter) to baseline concentrations
Time frame: At baseline and after 2 weeks IV treatment or after 4 weeks oral treatment and after 2 months treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suntje Sander-Struckmeier, PhD study director
Abbott
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ademetionine IV+tablet and Ademetionine tablet in people with Intrahepatic Cholestasis Associated With Alcoholic Liver Disease, run by Abbott at 12 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentrations (Units per liter) of Alkaline phosphatase (ALP) or gamma-glutamyltransferase (γGT) (time frame: from baseline up to the end of treatment visit (56-60 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2015.